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The Race to Develop Treatments and Vaccines for COVID-19
The coronavirus pandemic has now reached nearly every country in the world, with cases being confirmed in more than 200 countries and territories. As of April 10th, 2020, there have been over 1.6 million cases reported globally. The actual numbers of cases are believed to be much higher due to testing shortages, unreported cases, and suspicions that some countries have not been accurately reporting the scope of their outbreaks.
While most coronaviruses are not dangerous, the World Health Organization (WHO) identified a new strain after a December outbreak in China that is a cousin to the SARS virus. WHO officials named this new virus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), although most simply refer to it by its more popular name Coronavirus Disease 2019 (COVID-19).
COVID-19 is one of seven types of coronavirus that have been identified. Of those, some can cause serious disease like Middle East respiratory syndrome (MERS) and sudden acute respiratory syndrome (SARS). The others cause most of the colds we get throughout the year but are not a serious health threat for most people.
Common symptoms of COVID-19 can include cough, fever, and shortness of breath. While most cases are mild, some progress to viral pneumonia, organ failure and potentially death. As of April 10th, 2020, there have been just over 100,000 recorded deaths due to COVID-19. The people most at risk of becoming seriously ill due to this virus are those over 60, people taking immunosuppressive drugs (e.g., people who have undergone organ transplants), or those with pre-existing conditions such as cancer, diabetes, and heart disease.
With COVID-19 continuing to spread across the globe, many pharmaceutical and biotechnology companies are racing to develop vaccines and effective therapeutics to address the pandemic. As the premier laboratory informatics service provider for the life science industry, Astrix Technology Group is proud to support many of the companies on the front lines in this effort. In this blog, we will highlight some of the groundbreaking work being done right now by our customers to combat COVID-19.
The first time the body encounters a pathogen (e.g., COVID-19), it can take several days for the immune system to fully mobilize against the invader. One of the most powerful tools of our immune system – the antibodies that recognize, attack and destroy the infection – take the longest to generate. Vaccines work by exposing the body to a dead or weakened version of the pathogen. Our immune system responds by creating memory cells that recognize the invader and enable it to generate antibodies much faster if exposed in the future, effectively providing immunity to the disease.
A few of the Astrix customers working on COVID-19 vaccines include:
CSL Behring is collaborating with the University of Queensland in Australia to support a COVID-19 vaccine candidate by providing vaccine development expertise, laboratory facilities and proprietary technologies. In addition, CSL Behring is part of an alliance focused on developing a potential plasma-derived therapy for treating COVID-19. The collaboration will leverage work the companies already have done, beginning with the investigational development of one, unbranded anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin medicine that has potential to treat individuals suffering serious complications from COVID-19.
Emergent BioSolutions has entered into an agreement with Novavax, utilizing its contact development and manufacturing (CDMO) services to produce Novavax’s COVID-19 experimental vaccine candidate for clinical trials. Based on Novavax’s proprietary recombinant protein nanoparticle technology, the vaccine candidate is currently in the pre-clinical phase of development, with a phase 1 clinical trial expected to start in the next few months.
Johnson & Johnson (J&J) recently announced a lead COVID-19 vaccine candidate that is expected to enter human clinical studies by September 2020 at the latest. J&J has also partnered with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, to commit more than $1 billion of investment to co-fund vaccine research, development, and clinical testing. Finally, J&J and BARDA have committed additional funding to allow the expansion of their ongoing work to identify potential antiviral treatments against COVID-19.
Moderna received funding in January from the Coalition for Epidemic Preparedness Innovations (CEPI) to develop an mRNA vaccine for COVID-19. A phase 1 clinical trial to test an mRNA-1273 candidate began at Kaiser Permanente Washington Health Research Institute in Seattle on March 16th, and is expected to conclude on June 1st, 2021.
Pfizer recently announced that it would help German Life Science company BioNTech develop and distribute its COVID-19 vaccine candidate (BNT162) outside China, helping to cement a partnership to develop mRNA-based vaccines that has been in place for several years. The vaccine candidate is scheduled to go into clinical trials in late April, while talks with regulators around the world are well underway.
Sanofi is leveraging the company’s long-standing partnership with BARDA in hopes of accelerating development on a vaccine for COVID-19. The development work is centered around an advanced pre-clinical SARS vaccine that was developed over a decade ago for the SARS outbreak. This SARS vaccine was immunogenic and afforded partial protection as assessed in animal challenge models, and the hope is that this prior development work on a coronavirus vaccine will provide a head start for COVID-19.
While vaccines are an important tool to prevent people from getting sick with COVID-19 in the first place, several Astrix customers are also working on developing effective anti-viral treatments to help those people who do get sick.
Alnylam is expanding its collaboration with Vir Biotechnology to advance investigational RNAi therapeutics targeting host factors for the treatment of COVID-19. This expansion is focused on up to three host factor-targeting development candidates to treat COVID-19, which may be effective against other coronaviruses as well.
Amgen recently announced a collaboration with Adaptive Biotechnologies to discover and develop human virus-neutralizing antibodies to aid in the fight against COVID-19. As these antibodies defend healthy cells by interfering with the biological function of the COVID-19 virus, they could potentially be used both therapeutically and preventatively for individuals with a heightened risk of exposure (e.g., healthcare workers).
Biogen recently announced that they are partnering with Vir Biotechnology to advance the development and clinical manufacturing of Vir’s human monoclonal antibodies, first isolated from people who survived SARS, as a potential treatment for COVID-19.
Gilead recently announced the initiation of two phase 3 clinical studies to evaluate the safety and efficacy of its investigational compound remdesivir, a nucleotide analog that has demonstrated broad-spectrum anti-viral activity in preclinical studies against viral pathogens Ebola, Marburg, MERS and SARS.
Janssen, a subsidiary of Johnson & Johnson, donated its PREZCOBIX® HIV medication (darunavir/cobicistat) to Chinese health authorities for use in research aimed at finding a treatment for COVID-19. Anecdotal reports suggest that darunavir, a protease inhibitor, has antiviral activity against COVID-19.
Regeneron is working on two different COVID-19 treatments. The company started global phase 2/3 trials back in March for an arthritis medication (Kevzara) it partnered with Sanofi to produce after it showed promise as a treatment against COVID-19 in a single-arm comparator trial in China. Additionally, Regeneron is working on an antibody cocktail that could be used as either a vaccine or a treatment utilizing its proprietary VelociSuite technologies to produce human antibodies against COVID-19 from genetically edited mice.
With millions of people currently in lockdown, scientists around the globe are working to find treatments and/or vaccines for the coronavirus disease known as COVID-19. An experimental drug typically takes over a decade to go from discovery to commercialization, however, with compounds moving from early R&D efforts to laboratory and animal testing and then eventually clinical trials in people.
In order to speed the therapeutics pipeline and prevent this pandemic from getting worse, several Astrix customers highlighted in this blog are working with anti-viral compounds that have shown some efficacy with coronaviruses in vitro or with animals, or are already approved for other viral diseases. There is also much work being done to develop vaccines, although vaccines typically take longer to move through the pipeline than anti-viral medications. Still, companies are working hard to speed the COVID-19 vaccine candidate pipeline, and if clinical trials now in progress go well, we could have an approved COVID-19 vaccine available within 12 to 18 months.
Currently, the most effective way to stay healthy in the age of COVID-19 is simply to avoid exposure. That said, social distancing is not a sustainable strategy over the long haul. Fortunately, some of the world’s brightest minds are working hard on solutions that will serve to slow this pandemic and prevent it from happening again. At Astrix, we are proud to support these scientists in the laboratory who are working so hard to make our world a healthier place.